Enforcement Report - Week of August 29, 2012
-
| Product Type | Recalling Firm | Classification | Status | Distribution Pattern | Event Details |
|---|---|---|---|---|---|
| Biologics | Belle Bonfils Memorial Blood Center | Class II | Terminated | AZ | Details |
| Biologics | Belle Bonfils Memorial Blood Center | Class II | Terminated | Colorado, Switzerland | Details |
| Biologics | Community Blood Center of Greater Kansas City | Class II | Terminated | MO | Details |
| Biologics | Biomat USA, Inc. | Class II | Terminated | Spain | Details |
| Biologics | American Red Cross Blood Services | Class II | Terminated | OK, KY | Details |
| Biologics | American National Red Cross (The) | Class II | Terminated | Blood products were released for distribution to consignees located in CA. | Details |
| Biologics | Community Blood Center of Greater Kansas City | Class II | Terminated | MO | Details |
| Biologics | Community Blood Center of Greater Kansas City | Class II | Terminated | MO | Details |
| Biologics | Community Blood Center of Greater Kansas City | Class II | Terminated | MO | Details |
| Biologics | American National Red Cross (The) | Class III | Terminated | IN | Details |
| Biologics | Mississippi Valley Reg Bld Ctr | Class III | Terminated | Illinois | Details |
| Biologics | Mississippi Valley Reg Bld Ctr | Class II | Terminated | Kentucky | Details |
| Biologics | Belle Bonfils Memorial Blood Center | Class II | Terminated | CO, CA, Switzerland | Details |
| Biologics | Community Blood Bank of Lancaster County Medical Society | Class II | Terminated | NE | Details |
| Biologics | Bio-Blood Components, Inc. | Class III | Terminated | California. | Details |
| Biologics | Community Blood Center Of Gtr KC | Class III | Terminated | KS. | Details |
| Biologics | Mississippi Valley Regional Blood Center | Class II | Terminated | Iowa | Details |
| Biologics | Mississippi Valley Regional Blood Center | Class II | Terminated | Missouri, Iowa | Details |
| Biologics | Mississippi Valley Regional Blood Center | Class II | Terminated | Washington, D.C. | Details |
| Biologics | Community Blood Bank of Lancaster County Medical Society | Class II | Terminated | FL | Details |
| Biologics | Mississippi Valley Reg Bld Ctr | Class II | Terminated | Iowa | Details |
| Biologics | Community Blood Bank of Lancaster County Medical Society | Class II | Terminated | NE | Details |
| Biologics | Belle Bonfils Memorial Blood Center | Class II | Terminated | MI, Switzerland | Details |
| Biologics | Mississippi Valley Reg Bld Ctr | Class II | Terminated | Pennsylvania | Details |
| Biologics | American Red Cross Blood Services | Class II | Terminated | NE | Details |
| Biologics | Mississippi Valley Reg Bld Ctr | Class II | Terminated | Iowa, Illinois | Details |
| Biologics | Delta Blood Bank | Class II | Terminated | CA. | Details |
| Biologics | Belle Bonfils Memorial Blood Center | Class II | Terminated | CO, Switzerland | Details |
| Biologics | Delta Blood Bank | Class II | Terminated | CA and Austria | Details |
| Biologics | Mississippi Valley Regional Blood Center | Class II | Terminated | California, Missouri and Maryland | Details |
| Biologics | Blood Centers of the Pacific | Class III | Terminated | CA. | Details |
| Biologics | American Red Cross Blood Services | Class II,Class III | Terminated | TX, CA | Details |
| Biologics | BioLife Plasma Services L.P. | Class II | Terminated | CA | Details |
| Biologics | Plasma Care, Inc. dba Marion Blood Plasma, Inc. | Class II | Terminated | California. | Details |
| Biologics | Belle Bonfils Memorial Blood Center | Class II | Terminated | CO, Switzerland | Details |
| Biologics | American National Red Cross (The) | Class II | Terminated | KY, IN | Details |
| Biologics | Blood Center of Northcentral Wisconsin, Inc. | Class II | Terminated | WI, NY | Details |
| Biologics | CSL Plasma, Inc. | Class II | Terminated | IL, NC, CA. | Details |
| Biologics | Csl Plasma Inc | Class II | Terminated | Illinois | Details |
| Biologics | Delta Blood Bank | Class II | Terminated | CA. | Details |
| Biologics | New Life Generation, INC. | Class II,Class III | Ongoing | IN, CA, VA | Details |
| Biologics | Allograft Innovations, LLC | Class III | Ongoing | Products were distributed domestically to hospitals nationwide and internationally to Israel, South Korea, United Kingdom, and Turkey. | Details |
| Biologics | Delta Blood Bank | Class III | Terminated | CA, IN. | Details |
| Biologics | Delta Blood Bank | Class III | Terminated | CA, IN. | Details |
| Biologics | San Antonio Eye Bank | Class III | Terminated | CA, TX, FL | Details |
| Devices | Stryker Medical Division of Stryker Corporation | Class II | Ongoing | Worldwide Distribution -- USA (nationwide) including the states of AK, AL, AZ, CA, FL, ID, IN, KS, KY, LA, MA, MD, MN, MO, NC, NJ, NY, OR, PA, TN, TX, UT, UT, VA, WA, WI, and WV, and the country of Canada. | Details |
| Drugs | Morton Salt Co. | Class III | Ongoing | Nationwide & PR & Ireland. | Details |
| Biologics | Siemens Healthcare Diagnostics Inc. | Class II | Ongoing | Product was released for distribution in US and Internationally. The firm stated that National Competent Authorities notified in affected countries: Brazil, Thailand, and South Africa. | Details |
| Veterinary | Diamond Pet Foods | Class I | Ongoing | Distribution was made to AR, CO, IL, KY, LA, MI, MN, MO, OK, NE, PA, SD, TN, TX, and WI, | Details |
| Drugs | The Menz Club, LLC | Class I | Ongoing | Nationwide | Details |
| Devices | Exactech, Inc. | Class II | Ongoing | Nationwide distribution: USA including states of: AL, AZ, CO, FL, GA, IL, LA, MD, MN, NC, NJ, NY, OH, OK, PA, PR, TN, VA, and WA. | Details |
| Biologics | SightLife | Class II | Terminated | One cornea was shipped to each of 2 physicians in Japan. | Details |
| Devices | Abbott Point Of Care Inc. | Class II | Ongoing | Worldwide Distribution - US Nationwide, International | Details |
| Devices | Sunquest Information Systems, Inc. | Class III | Completed | US Nationwide Distribution | Details |
| Devices | Siemens Healthcare Diagnostics, Inc. | Class II | Ongoing | Worldwide Distribution-USA (nationwide) and the countries of Canada, France, Germany, Spain, Portugal, Italy, Japan, Norway, Australia, Austria, New Zealand, Belgium, Switzerland, Netherlands, Malaysia, Slovenia, South Korea, Denmark, Saudi Arabia, Slovakia, Taiwan, Philippines, Czech Republic, and Singapore. | Details |
| Veterinary | Mars Petcare USA | Class I | Ongoing | Product was shipped to the following states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI & WV. | Details |
| Food/Cosmetics | Breadfarm | Class II | Terminated | Distributed to retailers and direct accounts in Washington State. | Details |
| Drugs | Noven Pharmaceuticals, Inc. | Class II | Ongoing | Nationwide and Puerto Rico. | Details |
| Food/Cosmetics | KT Specialty Foods Inc. | Class II | Ongoing | Products are distributed in Oregon and Washington | Details |
| Drugs | Victus, Inc. | Class II | Ongoing | FL | Details |
| Food/Cosmetics | Peoples Bakery Inc | Class I | Ongoing | Mercer/Burlington counties in NJ | Details |
| Devices | Mckesson Medical Imaging Group | Class II | Ongoing | Worldwide Distribution - U.S. Nationwide and the countries of: Canada, France, Ireland and United Kingdom. | Details |
| Devices | Medtronic Navigation, Inc. | Class II | Ongoing | Worldwide Distribution - USA, including the states of AL, CO, FL, IA, MI, IA, NC, NE, NY and the countries of South Africa, Italy, and Spain. | Details |
| Devices | Conformis Inc | Class II | Ongoing | Worldwide Distribution - US Nationwide and the country of Germany | Details |
| Devices | Siemens Medical Solutions, USA, Inc | Class II | Ongoing | Nationwide Distribution -- MA, GA, MO, IA, CA, PA, OR, CO, NY, NJ, WA, UT, OH, WI, MI, KY, and NC. | Details |
| Food/Cosmetics | LD Amory & Company | Class II | Ongoing | The products were distributed to AZ, NC, and VA. | Details |
| Devices | Siemens Healthcare Diagnostics, Inc | Class II | Ongoing | Worldwide Distribution - US Nationwide and the countries of: Foreign: Brazil, China, Denmark, Hong Kong, Malaysia, and New Zealand Viet Nam | Details |
| Devices | CareFusion 303, Inc. | Class I | Ongoing | Worldwide Distribution-USA (nationwide) and the countries of Australia, European Union, and South Africa. | Details |
| Devices | DePuy Orthopaedics, Inc. | Class II | Ongoing | Worldwide Distribution - USA including PA and the country of Canada | Details |
| Devices | Stryker Spine | Class II | Ongoing | Distributed in Atlanta, Georgia. | Details |
| Food/Cosmetics | Cool Creations, LLC | Class I | Ongoing | Direct distribution was made to KS, MO, and OK. | Details |
| Food/Cosmetics | Wimberger's Old World Bakery, Inc. | Class I | Ongoing | The product was distributed to retailers located in Colorado and Kansas. | Details |
| Devices | Terumo Cardiovascular Systems Corporation | Class II | Ongoing | Worldwide Distribution - US Nationwide including the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, and WV and the countries of: AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Germany, Hong Kong, Indonesia, Japan, Jordan, Malaysia, Singapore, South Africa, South Korea, Taiwan, Thailand, UNITED ARAB EMIRATES (UAE), and Vietnam | Details |
| Food/Cosmetics | Freshpoint Atlanta, Inc. | Class I | Ongoing | AL, GA, NC, SC & TN. | Details |
| Food/Cosmetics | Huxtable's Kitchen Inc | Class I | Ongoing | Distributed to Trader Joes market stores CA, AZ, NV and NM. | Details |
| Devices | GE OEC Medical Systems, Inc | Class II | Ongoing | Worldwide Distribution -- USA (nationwide) | Details |
| Food/Cosmetics | Reshmi's Group Inc. | Class I | Ongoing | Product was further distributed to consignees in Alaska, Colorado, Oregon, and Washington | Details |
| Food/Cosmetics | Authentic Gourmet | Class II | Ongoing | CA | Details |
| Food/Cosmetics | Mother India foods LLC | Class I | Ongoing | Distributed in Oregon and Washington | Details |
| Devices | Beckman Coulter Inc. | Class II | Terminated | Worldwide distribution: USA (nationwide) and countries of: Algeria, Angola, Argentina, Australia, Austria, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea,Republic of; Kuwait, Liechtenstein, Malaysia, Mayotte, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Viet Nam. | Details |
| Food/Cosmetics | Tomales Bay Foods, Inc. | Class I,Class II | Completed | Part One: CA, VA, VT, WI, OR, UT and Italy, Spain, Switzerland, France, Holland, Greece. Part Two: Dates of Distribution: 6/2512 - 7/27/12 Pattern: CA, NC, FL | Details |
| Devices | GE OEC Medical Systems, Inc | Class II | Terminated | Worldwide and Nationwide (USA) distribution. | Details |
| Devices | GE OEC Medical Systems, Inc | Class II | Terminated | Nationwide Distribution. | Details |
| Devices | Biomet U.K., Ltd. | Class II | Ongoing | Worldwide Distribution-USA-including the states of IN, SD, and TX and the countries of Austria, China, Japan, Netherlands, Sweden, Turkey, and UK. | Details |
| Devices | GE OEC Medical Systems, Inc | Class II | Ongoing | Nationwide distribution. | Details |
| Devices | Sunquest Information Systems, Inc. | Class III | Terminated | Worldwide distribution: USA (nationwide) and country of: Bahamas. | Details |
| Devices | Beckman Coulter Inc. | Class II | Terminated | Worldwide Distribution-USA (nationwide) including the states GA, NY, IL, TX, WA, PA, IN, MS, NC, and MO and the countries of Belgium, France, Hong Kong, Italy, Spain, and Switzerland. | Details |
| Drugs | Prometheus Laboratories Inc. | Class II | Ongoing | Nationwide and Puerto Rico. | Details |
| Drugs | Custom Medical Specialties, Inc. | Class II | Ongoing | GA, MD, MA | Details |
| Food/Cosmetics | 2 Moms in the Raw, LLC | Class I | Ongoing | National US distribution only: OR, NY, KS, PA, CA, TX, NH, WA. | Details |
| Food/Cosmetics | Deep Foods Inc | Class I | Ongoing | Nationwide. | Details |
| Food/Cosmetics | Specialty Commodities, Inc. | Class I | Ongoing | CA, MN NJ, NY, OR, PA, SC, and Canada | Details |
| Food/Cosmetics | Flywheel's Pies | Class II | Ongoing | Arkansas | Details |
| Devices | Philips Medical Systems (Cleveland) Inc | Class II | Ongoing | Worldwide Distribution - US Nationwide including the states of: AL, AR, AZ, CA, DC, FL, GA, KY, MD, MI, MN, MS, ND, NM, NY, OH, OK, SC, TN, TX, VT, WA, and WI and the countries of: Austria, China, Denmark, France, Germany, Iceland, Japan, Netherlands, South Africa, Sweden, Switzerland, United Kingdom. There were two government consignees. There were no Canadian consignees. | Details |
| Devices | Beckman Coulter Inc. | Class III | Ongoing | Worldwide Distribution - USA (nationwide), Canada, and internationally. | Details |
| Food/Cosmetics | Menno Beachy | Class I | Ongoing | Distribution was made to a food distributor in MN who further distributed the product to retail stores located in MN, WI, and MI. | Details |
| Devices | AGFA Corp. | Class II | Ongoing | USA Nationwide, Virgin Islands and Canada | Details |
| Devices | GE OEC Medical Systems, Inc | Class II | Terminated | Worldwide Distribution - USA - Australia, Brazil, Cameroon, China, Colombia, Cyprus, The Czech Republic, Finland, France, Germany, Greece, Italy, Japan, Korea, Malaysia, The Netherlands, New Zealand, Norway, Russian Federation, Spain, Sweden, Taiwan, Turkey, UAE, UK, and Canada. | Details |
| Food/Cosmetics | Essential Living Foods, Inc | Class I | Completed | CA | Details |
| Food/Cosmetics | Fresco Green Farms, Inc. | Class I | Ongoing | CA | Details |
| Devices | Hitachi Medical Systems America Inc | Class II | Ongoing | US Nationwide Distribution - including the states of:: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and Mexico. | Details |
| Devices | Galil Medical, Inc. | Class II | Completed | Worldwide Distribution - US nationwide including the state of MN and the countries of United Kingdom and Netherlands | Details |
| Devices | Philips Medical Systems (Cleveland) Inc | Class II | Ongoing | Nationwide Distribution-including the states of CO, FL, MD, MN, NE and PA. | Details |
| Drugs | VistaPharm, Inc. | Class II | Ongoing | Nationwide | Details |
| Food/Cosmetics | Winn Dixie Stores, Inc. | Class II | Ongoing | SC | Details |
| Food/Cosmetics | J&S Group | Class II | Ongoing | CA, IL | Details |
| Food/Cosmetics | Spartan Central Kitchen | Class II | Ongoing | MI distribution only | Details |
-
